An interventional study of endoscopic retrograde biliary drainage (single plastic stent) and endoscopic retrograde biliary drainage ( fully covered self-expanding metal stent) in Chronic Pancreatitis and Benign Biliary Stricture, sponsored by Changhai Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-18.
Sponsored by Changhai Hospital · Not applicable, Interventional, and Treatment
Among 41 studies in Pancreatitis, Chronic by Changhai Hospital — 13 open to participants now, 18 under way, none of them phase 3. Pancreatitis, Chronic · Changhai Hospital.
Among the 41 studies in Pancreatitis, Chronic by Changhai Hospital, this one is the 7th largest by planned enrollment of the 13 interventional ones that give a count, is one of 9 that started in 2025, is one of 11 with no phase, reaches primary completion later than 16 of the 17 other live ones, and was the 29th registered.
264 studies on the registry are indexed under Pancreatitis, Chronic; 76 are open to participants now.
Browse Pancreatitis, Chronic studies →13 of the 41 studies in Pancreatitis, Chronic by Changhai Hospital are open now, in 1 country. Recruiting first, the newest first:
Changhai Hospital · Sites in China
Changhai Hospital · Sites in China
Changhai Hospital · Sites in China
Changhai Hospital · Sites in China
Changhai Hospital · Sites in China
By country, each count listing its studies:
Of the 49 Pancreatitis, Chronic studies recruiting now, 31 (63%) set no upper age limit and 12 (24%) stop at 75 or younger; 8 take children under 18; 11 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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41 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 9 started in 2025.
This study's planned enrollment of 134 is above the median of 45 across 143 interventional studies indexed under Pancreatitis, Chronic.
Median enrollment 134 across the 13 interventional studies, 657 across the 28 observational. Of the 15 that completed or were terminated, 1 (7%) have results posted.
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Changhai Hospital is the lead sponsor of 355 studies on the registry; 137 are open to participants now.
1 of the studies in Pancreatitis, Chronic by Changhai Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03324698Changhai HospitalThe Natural History of Chronic Pancreatitis | 2026-12-31 |
Among the 41 studies in Pancreatitis, Chronic by Changhai Hospital, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The goal of this clinical trial is to compare the efficacy and safety of a single plastic stent versus a fully covered self-expanded metal stent in relieving benign biliary stricture secondary to chronic pancreatitis. The main questions it aims to answer is:
Whether the efficacy of a single plastic stent is non-inferior to that of a fully covered metal stent in patients with benign biliary stricture secondary to chronic pancreatitis？
Participants will be randomly assigned to receive either a single plastic stent (SPS) placement or fully covered self-expanded metal stent placement treatment for 6 months, and they will be followed up for 18 months.
Although a number of previous studies have shown that the drainage and dilation effect of a single plastic stent is limited for benign biliary stricture (BBS) secondary to chronic pancreatitis (CP), the poor management of CP itself in most studies may explain the unsatisfactory efficacy of a single biliary plastic stent in relieving CP secondary BBS. Investigators believe that the effective management of CP is an important step to solve the BBS secondary to CP, especially the effective removal of pancreatic duct stones, the relief of pancreatic duct obstruction and the maintenance of pancreatic duct patency. Previous data showed that in CP patients treated with ESWL combined with ERCP, 72.4% could achieve complete removal of main pancreatic duct stones and 90.8% could achieve successful endoscopic decompression. Under the premise of effectively removing the stones of the main pancreatic duct at the head of the pancreas and maintaining the patency of the pancreatic duct, using a single plastic stent for stent drainage of BBS is effective, and a single plastic stent has potential advantages such as lower stent displacement rate and cheaper. Therefore, investigators design a single-center, prospective, open-label, randomized controlled, non-inferiority trial to compare the effectiveness, safety, and cost-effectiveness of a single plastic stent and fcSEMS for the removal of CP secondary BBS under the premise that the primary disease, i.e. CP itself, was effectively managed.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A single biliary fcSEMS will be placed under ERCP. During stenting period , if symptoms of biliary obstruction occur due to stent occlusion or migration, ERCP replacement or implantation of a new stent should be performed according to the condition. After 6 months of stenting, imaging evaluation will be performed. ERCP is not needed if the stent undergoes spontaneous complete distal migration and the patient is asymptomatic and has normal liver function. If the stent is visible, ERCP will be performed to remove the stent and the stricture will be evaluated. If stricture persists after 6 months of stenting, a follow-up treatment plan should be developed through multidisciplinary discussion. One month after ERCP, complications will be followed up by telephone. Follow-up after biliary stent removal will be conducted to inquire about symptoms, signs and liver function test results, and to evaluate the recurrence of biliary stricture.
Device: endoscopic retrograde biliary drainage ( fully covered self-expanding metal stent)
A single biliary plastic stent will be placed under ERCP. During stenting period , if symptoms of biliary obstruction occur due to stent occlusion or migration, ERCP replacement or implantation of a new stent should be performed according to the condition. After 6 months of stenting, imaging evaluation will be performed. ERCP is not needed if the stent undergoes spontaneous complete distal migration and the patient is asymptomatic and has normal liver function. If the stent is visible, ERCP will be performed to remove the stent and the stricture will be evaluated. If stricture persists after 6 months of stenting, a follow-up treatment plan should be developed through multidisciplinary discussion. One month after ERCP, complications will be followed up by telephone. Follow-up after biliary stent removal will be conducted to inquire about symptoms, signs and liver function test results, and to evaluate the recurrence of biliary stricture.
Device: endoscopic retrograde biliary drainage (single plastic stent)
Participants will undergo ERCP. A flexible tube is inserted into the duodenum, crossing the sphincter of Oddi to access the biliary system. And the location, diameter, and length of biliary stricture will be evaluated by injection of contrast media. A single plastic stent is then placed across the biliary stricture, allowing the bile duct to resume drainage. The participants will be observed closely after ERCP and record complications. Imaging evaluation will be conducted 6 months after stenting to confirm spontaneous passage of the biliary duct stent, and the stent will be removed via ERCP if it is still in place.
Participants will undergo ERCP. A flexible tube is inserted into the duodenum, crossing the sphincter of Oddi to access the biliary system. And the location, diameter, and length of biliary stricture will be evaluated by injection of contrast media. A fully covered self-expanding metal stent is then placed across the biliary stricture, allowing the bile duct to resume drainage. The participants will be observed closely after ERCP and record complications. Imaging evaluation will be conducted 6 months after stenting to confirm spontaneous passage of the biliary duct stent, and the stent will be removed via ERCP if it is still in place.
Long-term stricture resolution
Stricture resolution assessed at the time of final stent removal as well as the absence of objective findings of stricture recurrence during the 18 months, post-stenting follow-up period.
Time frame: 2 years after enrollment
Early clinical success
Stricture resolution at the time all stent is removed. If there is a persistent stricture after 6 months of stent therapy in either group, the patient will be classified as a clinical failure.
Time frame: 6 months after enrollment
Technical success
The completion of the initial and each follow-up ERCP, including stent deployment and removal.
Time frame: 6 months after enrollment
Adverse events related to the device or procedure
Device or procedure related adverse events from the initial stent placement procedure to the 2 year follow-up.
Time frame: 2 years after enrollment
Length of stent placement and removal procedures
Length of stent placement procedures and stent removal procedures.
Time frame: 6 months after enrollment
Number of ERCP procedures after Initial stent placement.
The number of endoscopic retrograde cholangiopancreatography (ERCP) procedures after initial stent placement.
Time frame: 6 months after enrollment
Number of stents placed
The total number of stents placed
Time frame: 6 months after enrollment
Plan to share: No
Started Apr 2025 (actual). Primary completion is estimated for Dec 2030, 68 months after the start.
Of 46 non-industry interventional studies with no phase under Pancreatitis, Chronic, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 64. This study's planned 68 months is above that.
Counting every sponsor, half of 49 studies reached it within 32 months; a quarter within 18 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
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